FDAFDA · Food and drugs·Recall number Z-0912-2013
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Published March 13, 2013 · Recall initiated: January 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Atricure Inc
- Distributor
- Nationwide Distribution including the states of MD, PA and TX.
- Lot
- Model Number(s): MAX1 A000163, Lot Number 41865
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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